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Trial registered on ANZCTR
Registration number
ACTRN12624001066572
Ethics application status
Approved
Date submitted
19/08/2024
Date registered
3/09/2024
Date last updated
3/09/2024
Date data sharing statement initially provided
3/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
IMplementing clinical Pathways for Acute Care in Tasmania (IMPACT)
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Scientific title
Co-designing and evaluating the implementation of clinical pathways for acute care in Tasmania
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Secondary ID [1]
312785
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MRF2018041
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chest pain
334840
0
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fractured neck of femur
334841
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stroke
334842
0
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sepsis
334843
0
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Condition category
Condition code
Emergency medicine
331397
331397
0
0
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Other emergency care
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Cardiovascular
331438
331438
0
0
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Coronary heart disease
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Injuries and Accidents
331439
331439
0
0
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Fractures
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Stroke
331440
331440
0
0
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Ischaemic
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Stroke
331441
331441
0
0
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Haemorrhagic
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Public Health
331442
331442
0
0
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Health service research
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Infection
331443
331443
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In partnership with the health sector in each Tasmanian ED, we will identify, and explore the factors influencing practice variation for clinical pathways used in these EDs and develop targeted implementation strategies as part of an Implementation and Evaluation Toolkit (IET). An established, proven theory informed, co-designed approach to developing the strategies will be used. Using the Theoretical Domains Framework (TDF), qualitative interviews or focus groups will explore individual and organisational factors that contribute to variations in practice at each location. The TDF incorporates a range of behaviour change theories for use in implementation research. The validated TDF has demonstrated strong explanatory and predictive powers across health care, including acute care settings, and is particularly useful when selecting interventions to improve practice. Implementation strategies will be co-designed with clinicians at each hospital, taking into consideration the likelihood of the strategies impacting the identified influencing factors (grouped by TDF domains), evidence of their effectiveness and their acceptability/feasibility in the hospital setting. Assessments of ex-ante cost-effectiveness will also be used to support decision-making.
The intervention will be an implementation toolkit for 4 clinical pathways used in ED: 1) Chest Pain 2) Suspected Stroke 3) Fractured Neck of Femur and 4) Suspected Sepsis.
The intervention will be co-designed with clinicians. The toolkit has therefore yet to be developed and may be different at each site.
Broadly, the physical or informational materials used will include education activities by champions within the health service, changes to how and where clinical pathways are accessed as well as audit and feedback as part of service delivery.
The intervention will be delivered by the research team in conjunction with health service staff.
The mode of delivery will be multimodal - education, system changes to how pathways are accessed and technology changes to incorporate audit and feedback into routine care.
The number of times that the intervention will be delivered will be determined following co design and understanding of health service workload and built in implementation strategies. We aim to implement the toolkit over a 6 month period prior to evaluation.
the location of the intervention will be all four Tasmanian public EDs: North West Regional Hospital, Mersey Community Hospital, Launceston General Hospital and royal Hobart Hospital EDs.
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Intervention code [1]
329314
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Treatment: Other
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Intervention code [2]
329353
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Behaviour
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Comparator / control treatment
This is a health service implementation study where the intervention is a co-designed implementation toolkit.
To determine baseline performance characteristics, we will retrospectively ascertain all points on the clinical pathways for patients who were eligible for the pathway. For the period 1 January 2021 to 31 December 2021, data from 200 eligible patient medical records (100 from THS-South (Royal Hobart Hospital), 50 from THS-N (Launceston General Hospital) and 50 from THS-NW (North West Regional Hospital and Mersey Community Hospital), identified by triage descriptors and confirmed by chart review, will be extracted, recording variables relevant for each of the four clinical pathways, and indicators of adherence to the pathways determined. This approach is being used as it offers a pragmatic and feasible design largely limited by the analogue medical records system used by the health services. Key outcome data include length of stay in EDs, 28-day representation to EDs, hospital length of stay, in-hospital complications, and death.
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Control group
Historical
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Outcomes
Primary outcome [1]
339145
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Clinical pathway compliance
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Assessment method [1]
339145
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Triage descriptions will determine if a patient was eligible for a clinical pathway.
Administrative data and hospital records will be accessed for these patients to a) determine if a clinical pathway was used or not and b) if the elements of the clinical pathway were completed regardless if the pathway was used or not.
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Timepoint [1]
339145
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1 year of baseline data (1 Jan 2021 to 31 Dec 2021) and 1 year of data commencing 6 months after implementation of the co-designed toolkit
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Secondary outcome [1]
438753
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Sustainability of implementation toolkit
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Assessment method [1]
438753
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Sustainability of the implementation intervention will be assessed by evaluating ongoing clinical pathway adherence at one month periods at 18 months post implementation and 24 months post implementation using the same audit tool to assess baseline adherence, that is, an audit of all patients eligible for the clinical pathway and all patients where a clinical pathway was recorded in their medical records.
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Timepoint [1]
438753
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18 months post implementation and 24 months post implementation
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Eligibility
Key inclusion criteria
the measure of outcomes will include 4 specific pathways: chest pain, suspected stroke, suspected sepsis and fractured neck of femur
All patients within the study period who are eligible for one of these four pathways will be included in the study.
eligibility includes:
1) Chest pain pathway: triage description including chest pain as a presenting complaint
2) Suspected stroke pathway: triage description including suspicion of stroke as an assessment
3) Fractured Neck of Femur: Diagnosis of fractured neck of femur for that ED episode
4) Suspected sepsis pathway: blood cultures ordered by treating clinician
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who have been treated and transferred between study EDs
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2026
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Actual
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Date of last participant enrolment
Anticipated
31/12/2027
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Actual
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Date of last data collection
Anticipated
29/02/2028
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
TAS
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Funding & Sponsors
Funding source category [1]
317218
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Government body
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Name [1]
317218
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Medical Research Futures Fund, Department of Health and Aged Care
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Address [1]
317218
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Country [1]
317218
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Australia
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Primary sponsor type
University
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Name
University of Tasmania
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Address
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Country
Australia
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Secondary sponsor category [1]
319489
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Hospital
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Name [1]
319489
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Royal Hobart Hospital
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Address [1]
319489
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Country [1]
319489
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Australia
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Secondary sponsor category [2]
319491
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Hospital
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Name [2]
319491
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Launceston General Hospital
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Address [2]
319491
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Country [2]
319491
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Australia
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Secondary sponsor category [3]
319492
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Hospital
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Name [3]
319492
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Mersey Community Hospital
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Address [3]
319492
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Country [3]
319492
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Australia
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Secondary sponsor category [4]
319493
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Hospital
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Name [4]
319493
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North West Regional Hospital
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Address [4]
319493
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Country [4]
319493
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315953
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University of Tasmania Human Research Ethics Committee
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Ethics committee address [1]
315953
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http://www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu
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Ethics committee country [1]
315953
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Australia
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Date submitted for ethics approval [1]
315953
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09/03/2023
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Approval date [1]
315953
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19/05/2023
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Ethics approval number [1]
315953
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Summary
Brief summary
By embedding implementation science principles, IMPACT will enable the incorporation of clinical pathways into contemporary, patient-centred models of care across Tasmanian emergency departments (EDs) and the broader health sector, thereby improving the quality, efficiency and experience of acute care. The project will engage with all relevant stakeholders (consumers, ED clinicians, other community- and hospital-based health professionals, and policy makers). The experience in Tasmania will inform the development of a national acute care implementation science laboratory. We will reduce variation in care, improve service delivery, outcomes and efficiency of acute care, reduce pressure on EDs, and generate new knowledge applicable to assisting Australians living in rural and regional communities, when they are at their most vulnerable.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
136330
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A/Prof Viet Tran
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Address
136330
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Emergency Department, Royal Hobart Hospital, 48 Liverpool Street, Hobart TAS 7000
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Country
136330
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Australia
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Phone
136330
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+61 431225509
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Fax
136330
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Email
136330
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[email protected]
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Contact person for public queries
Name
136331
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Viet Tran
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Address
136331
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Emergency Department, Royal Hobart Hospital, 48 Liverpool Street, Hobart TAS 7000
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Country
136331
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Australia
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Phone
136331
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+61 431225509
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Fax
136331
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Email
136331
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[email protected]
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Contact person for scientific queries
Name
136332
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Viet Tran
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Address
136332
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Emergency Department, Royal Hobart Hospital, 48 Liverpool Street, Hobart TAS 7000
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Country
136332
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Australia
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Phone
136332
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+61 431225509
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Fax
136332
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Email
136332
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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